Validated Analytical method Development of Desvenlafaxine succinate in solid dosage form by RP-HPLC and HPTLC methods

The objective of this work was to develop and validate simple, rapid and accurate chromatographic methods (A and B) for determination of Desvenlafaxine succinate in solid dosage form. In method A - RP-HPLC method was based on Reversed Phase High Performance Liquid Chromatography, on ODS C18 RP column (150 mm × 4.6 mm i.d., 5 µ), using Methanol : 50 mM Phosphate buffer (pH 8.0): Acetonitrile (50:40:10 % v/v) as the mobile phase, at a flow rate of 1 mL/min at ambient temperature. Quantification was achieved by UV detection at 225 nm over a concentration range of 5-25 µg/mL for Desvenlafaxine succinate. The mean retention time for Desvenlafaxine succinate was found to be 4.80 min. The amount of Desvenlafaxine succinate estimated as percentage label claim was found to be 99.83 ± 1.1093. In method B - HPTLC method was based on TLC separation of the drug using silica gel 60 F 254 aluminium sheets and Chloroform : Methanol : Water (60:30:10 v/v/v) as mobile phase. Detection was carried out at 226 nm over the concentration of 1 - 3.5 µg/mL Desvenlafaxine Succinate. The mean Rf value of Desvenlafaxine succinate was found to be 0.63. The amount of Desvenlafaxine succinate was estimated as percentage label claim found to be 101.57 ± 0.92668. Both of these methods were found to be simple, precise, accurate, selective and could be successfully applied for determination of pure laboratory prepared mixture and tablet. Key words: RP-HPLC, HPTLC, Desvenlafaxine succinate, marketed formulation.